Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis

NCT06398223 | Recruiting

• 1 other identifier: OPHT-101023
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the presented study is to evaluate ocular blood flow, respectively optic nerve head blood flow in patients with carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting. Additionally, the investigators aim to compare optic nerve head blood flow in patients with CAS and healthy age- and sex-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Optic nerve head blood flow

  Change in optic nerve head blood flow (LSFG) in patients with unilateral carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting

  Before and 4-6 weeks after CEA or carotid artery stenting

Secondary Outcomes (1)

• Retinal oxygen saturation and retinal vessel diameter

  Before and 4-6 weeks after CEA or carotid artery stenting

Other Outcomes (9)

• Neurovascular coupling

  Before and 4-6 weeks after CEA or carotid artery stenting

• Retinal nerve fiber layer thickness

  Before and 4-6 weeks after CEA or carotid artery stenting

• Retinal thickness

  Before and 4-6 weeks after CEA or carotid artery stenting

Study Arms (3)

Carotid endarterectomy (CEA) (Group 1)

Subjects with unilateral carotid artery stenosis and planned CEA

Procedure: Carotid endarterectomy (CEA)

Carotid artery stenting (Group 2)

Subjects with unilateral carotid artery stenosis and planned carotid artery stenting

Procedure: Carotid artery stenting

Healthy Control Group (Group 3)

Healthy age- and sex-matched control subjects

Interventions

Carotid endarterectomy (CEA) PROCEDURE

Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery.

Carotid endarterectomy (CEA) (Group 1)

Carotid artery stenting PROCEDURE

Carotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated.

Carotid artery stenting (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 45 patients will be included in the study: * 15 subjects with unilateral carotid artery stenosis and planned CEA * 15 subjects with unilateral carotid artery stenosis and planned carotid artery stenting * 15 healthy age- and sex-matched control subjects

You may qualify if:

• Men and Women aged ≥ 18 years
• Signed informed consent
• Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
• Diagnosis of unilateral carotid artery stenosis and scheduled carotid endarterectomy or carotid artery stenting
• Men and Women aged ≥ 18 years
• Signed informed consent
• Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
• Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant
• Non-Smokers

You may not qualify if:

• Blood donation in the three weeks preceding the study
• Symptoms of a clinically relevant illness in the three weeks preceding the study
• Ocular inflammation or infection within the last 3 months
• History of family history of epilepsy
• Diabetes mellitus type 1 or type 2
• Pregnant or breast-feeding women
• Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clincal Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (14)

• Ismail A, Ravipati S, Gonzalez-Hernandez D, Mahmood H, Imran A, Munoz EJ, Naeem S, Abdin ZU, Siddiqui HF. Carotid Artery Stenosis: A Look Into the Diagnostic and Management Strategies, and Related Complications. Cureus. 2023 May 9;15(5):e38794. doi: 10.7759/cureus.38794. eCollection 2023 May.

  PMID: 37303351 BACKGROUND

• Lahme L, Marchiori E, Panuccio G, Nelis P, Schubert F, Mihailovic N, Torsello G, Eter N, Alnawaiseh M. Changes in retinal flow density measured by optical coherence tomography angiography in patients with carotid artery stenosis after carotid endarterectomy. Sci Rep. 2018 Nov 21;8(1):17161. doi: 10.1038/s41598-018-35556-4.

  PMID: 30464189 BACKGROUND

• Pierro L, Arrigo A, De Crescenzo M, Aragona E, Chiesa R, Castellano R, Catenaccio B, Bandello F. Quantitative Optical Coherence Tomography Angiography Detects Retinal Perfusion Changes in Carotid Artery Stenosis. Front Neurosci. 2021 Apr 22;15:640666. doi: 10.3389/fnins.2021.640666. eCollection 2021.

  PMID: 33967678 BACKGROUND

• Woo SY, Joh JH, Han SA, Park HC. Prevalence and risk factors for atherosclerotic carotid stenosis and plaque: A population-based screening study. Medicine (Baltimore). 2017 Jan;96(4):e5999. doi: 10.1097/MD.0000000000005999.

  PMID: 28121957 BACKGROUND

• Hackam DG. Optimal Medical Management of Asymptomatic Carotid Stenosis. Stroke. 2021 Jun;52(6):2191-2198. doi: 10.1161/STROKEAHA.120.033994. Epub 2021 May 5.

  PMID: 33947208 BACKGROUND

• Kwapong WR, Liu J, Wan J, Tao W, Ye C, Wu B. Retinal Thickness Correlates with Cerebral Hemodynamic Changes in Patients with Carotid Artery Stenosis. Brain Sci. 2022 Jul 25;12(8):979. doi: 10.3390/brainsci12080979.

  PMID: 35892420 BACKGROUND

• Song P, Fang Z, Wang H, Cai Y, Rahimi K, Zhu Y, Fowkes FGR, Fowkes FJI, Rudan I. Global and regional prevalence, burden, and risk factors for carotid atherosclerosis: a systematic review, meta-analysis, and modelling study. Lancet Glob Health. 2020 May;8(5):e721-e729. doi: 10.1016/S2214-109X(20)30117-0.

  PMID: 32353319 BACKGROUND

• Cohen R, Padilla J, Light D, Diller R. Carotid artery occlusive disease and ocular manifestations: Importance of identifying patients at risk. Optometry. 2010 Jul;81(7):359-63. doi: 10.1016/j.optm.2009.10.013.

  PMID: 20630374 BACKGROUND

• Batu Oto B, Kilicarslan O, Kayadibi Y, Yilmaz Cebi A, Adaletli I, Yildirim SR. Retinal Microvascular Changes in Internal Carotid Artery Stenosis. J Clin Med. 2023 Sep 16;12(18):6014. doi: 10.3390/jcm12186014.

  PMID: 37762953 BACKGROUND

• Arthur A, Alexander A, Bal S, Sivadasan A, Aaron S. Ophthalmic masquerades of the atherosclerotic carotids. Indian J Ophthalmol. 2014 Apr;62(4):472-6. doi: 10.4103/0301-4738.121183.

  PMID: 24817748 BACKGROUND

• Mursch-Edlmayr AS, Luft N, Podkowinski D, Ring M, Schmetterer L, Bolz M. Laser speckle flowgraphy derived characteristics of optic nerve head perfusion in normal tension glaucoma and healthy individuals: a Pilot study. Sci Rep. 2018 Mar 28;8(1):5343. doi: 10.1038/s41598-018-23149-0.

  PMID: 29593269 BACKGROUND

• Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Ocular Blood Flow Measurements in Healthy White Subjects Using Laser Speckle Flowgraphy. PLoS One. 2016 Dec 13;11(12):e0168190. doi: 10.1371/journal.pone.0168190. eCollection 2016.

  PMID: 27959905 BACKGROUND

• Bissacco D, Attisani L, Settembrini AM, Fossati A, Carmo M, Dallatana R, Settembrini PG. Modifications in Near Infrared Spectroscopy for Cerebral Monitoring During Carotid Endarterectomy in Asymptomatic and Symptomatic Patients. Ann Vasc Surg. 2022 Feb;79:239-246. doi: 10.1016/j.avsg.2021.06.047. Epub 2021 Oct 10.

  PMID: 34644636 BACKGROUND

• Ismail A, Chen HC, Faye I, Tang TB. Longitudinal effects of common carotid artery stenosis on ocular hemodynamics assessed using laser speckle flowgraphy in a rabbit model. Sci Rep. 2020 Sep 28;10(1):15829. doi: 10.1038/s41598-020-72556-9.

  PMID: 32985560 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD

CONTACT

+43 1 40400 29880; klin-pharmakologie@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr. med. univ.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 3, 2024
• Study Start: April 9, 2024
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

AU (1)